Inoperable or Metastatic Tumors
Hyperthermia (heat) can
increase the effect of chemotherapy treatments. By itself, it can also kill cancer
cells. By using heat to treat the
whole body, we can treat cancer cells wherever they are throughout the
entire body. In this study, we are
testing the combination of heat treatment and chemotherapy to see:
it improves the effect of the chemotherapy drugs,
it helps the body fight the cancer cells, and,
this treatment is safe and pleasant for the patient.
This study does not offer heat treatment alone. Any patient with inoperable or metastatic
neuroendocrin tumors (any organ), gastric, cholangiocarcinoma, small-bowel,
lung, head and neck, or melanoma may be treated; however, the patient will
need to undergo some medical tests to make sure this treatment would be
safe for them.
Once you have been accepted for this study, the patient will
need to have a Central Venous line (CV line or port) inserted if they do
not already have one. (You may have
this done by your doctor or we would be happy to help you with this
procedure as well.)
The treatment cycle begins with 6 hours of intravenous (IV)
hydration followed by an infusion of the anti-cancer drug, Cisplatin. In addition, at the beginning of this
treatment, you will begin receiving low-dose Interferon-a injections – once
a day – for the entire duration of your participation in this study. The drug, Interferon-a, interrupts the
division of cancer cells and slows tumor growth.
Thirty-six hours after the Cisplatin infusion, the patient is
treated with fever-range thermal therapy (whole-body heat). When the core body temperature reaches
104 degrees F (40 degrees C), a 30-minute (IV) infusion of another
chemotherapy drug, Gemcitabin (gemzar) is given. Cisplatin, low-dose Interferon-a and
Gemcitabine are the only chemotherapy drugs used in this treatment
plan. No other chemotherapy drugs
are allowed to be given under this treatment plan.
The fever-range whole-body heat treatment is performed while
the patient is under light conscious sedation. With this type of sedation, you will be
awake during the treatment but you will not be uncomfortable. This type of sedation method is used to
reduce the discomfort of the 6-hours heat treatment procedure yet allows
the patient to respond to verbal commands.
The patients’ body temperature is raised to 104 degrees F (40
degrees C) over a period of 60-120 minutes.
When the body first reaches the target 104 degrees F, we administer
the Gemcitabine chemotherapy over 60 minutes and continue to maintain the
104 degrees F body temperature for six hours. At the conclusion of the six hours of
heat treatment, the patient is cooled off to their normal body temperature,
which takes about 30 to 45 minutes.
The entire procedure lasts approximately 8 hours. After the treatment is completed, we
observe the patient for 2 to 24 hours to make sure the treatment has been
The patient will continue the daily low-dose
Interferon-a. Additionally, the
patient will be given daily Leukin (sargramostim) cytokine injections
usually beginning 3 to 5 days after receiving chemotherapy to help support
the immune system by helping the body create more white blood cells, which
are important in helping your body fight infection.
After treatment, the patient will need a complete blood count
with platelet and differential count each week. These lab studies can be done at the
patient’s own doctor’s office or hospital as long as you make sure that the
results are faxed to us. They can
also be done in our clinic. We will
see a patient again approximately three to four weeks and the treatment
cycle will be repeated.
We always attempt to perform at least two thermo-chemotherapy
cycles. After the second treatment,
CT and/or MRI scans are repeated to see if the tumor has changed. These scans, along with a physical
examination and the lab studies, are used to determine if additional heat
treatments will be performed.
Additional treatments continue based on how well a patient responds
to the treatment. There is no limit
to the number of heat treatments a patient may have.
Source: National Cancer Institute
To learn more about clinical trials visit the National
Cancer Institute Clinical Trials Homepage